Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
348
Countries
4
Sites
16
Advanced Solid tumour
Key facts
- Sponsor
- Corbus Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Feb 2025 → ongoing
- Decision date (initial)
- 2025-01-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid tumour
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Corbus Pharmaceuticals Inc.
- Sponsor organisation
- Corbus Pharmaceuticals Inc.
- Address
- 500 River Ridge Drive
- City
- Norwood
- Postcode
- 02062-5045
- Country
- United States
Scientific contact point
- Organisation
- Corbus Pharmaceuticals Inc.
- Contact name
- Ian Hodgson
Public contact point
- Organisation
- Corbus Pharmaceuticals Inc.
- Contact name
- Ian Hodgson
Locations
4 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 32 | 4 |
| Italy | Ongoing, recruiting | 32 | 4 |
| Romania | Ongoing, recruiting | 32 | 4 |
| Spain | Ongoing, recruiting | 32 | 4 |
| Rest of world
Turkey, United States, United Kingdom
|
— | 220 | — |
Investigational sites
Institut Gustave Roussy
Early Drug Development and Genitourinary Oncology Group, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology, Largo Francesco Vito 1, 00168, Rome
Careggi University Hospital
Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-03-12 | 2025-04-23 | |||
| Italy | 2025-05-09 | 2025-05-12 | |||
| Romania | 2025-02-24 | 2025-03-13 | |||
| Spain | 2025-02-25 | 2025-03-18 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-19 | Spain | Acceptable 2025-01-27
|
2025-01-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-11 | Acceptable | 2025-03-27 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-02 | Acceptable | 2025-04-02 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-17 | Spain | Acceptable 2025-07-09
|
2025-07-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-25 | Spain | Acceptable 2026-02-06
|
2026-02-10 |